DeviceClearance

Product code QTF— Cardiovascular

NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter

Classification name
Reprocessed Atherectomy Catheter
Device class
Class 2
Regulation
21 CFR 870.4875
Advisory panel
Cardiovascular
Total cleared
1
First cleared
Most recent

FDA classification definition

“Reprocessed atherectomy device for peripheral vasculature. Reprocessing validation data for this device type must be included in a 510(k) submission”

— U.S. Food and Drug Administration, device classification record for product code QTF under 21 CFR 870.4875, via openFDA

Market context for product code QTF

FDA has cleared 1 device under product code QTF, all in 2022, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QTF

Recent clearances under product code QTF

Data sourced from openFDA. This site is unofficial and independent of the FDA.